EOF is reminiscent of an injection solution as glass particles are detected

One product EOF recalls is a solution given to kidney transplant recipients. Inherent glass particles were found in the ampoules, so it was decided to recall a specific batch.

EOF also decided to recall two dietary supplements for containing unapproved food additives.

The products that EOF has decided to recall are:

SIMULECT PS.SOL.INF 20,g/vial BT x 1vial + 1amp solv (Package SHMM1 Expires 8/2025 is withdrawn)
226ERS Vegetarian Vitamin +
226ERS Vegetarian Magnesium Bisglycinate

SIMULECT is a powder and solvent for solution for injection with the active ingredient basiliximab. It acts as an interleukin inhibitor — among other things — given to kidney transplant recipients.

After informing NOVARTIS (HELLAS) SA, the reason for the recall of this particular batch was the detection of native glass particles in the ampoules of the solvent with batch number M0797.

EOF declaration on SIMULECT

We decide

Withdrawal of batch SHMM1 with expiry date 8/2025 of the medicinal product SIMULECT PS.SOL.INF 20,g/vial BT x 1vial + 1amp solv, glass particles in solvent ampoules by NOVARTIS (HELLAS) SA following notification of native availability.
With lot number M0797.

The company NOVARTIS (HELLAS) SA, as a local representative, should immediately contact the product recipients to provide instructions in the case of changing the solvent.

Alternatively, due to a notified shortage, in consultation with the company, only the solvent (package M0797) will be replaced with a corresponding product with a marketing license in Greece to be used for reconstitution of the product.

226ERS Dietary Supplement Notice

We decide

The circulation and distribution of nutritional supplements 226ERS VEGAN VITAMIN+ and 226ERS VEGAN MAGNESIUM BISGLYCINATE have been banned by the Spanish authorities, as they contain unauthorized food additives and do not comply with European regulations. Parliament on Food Additives.

The supplier of the product is 226ERS Sports Things, SL, a company based in Spain.

Product not declared to EOF.